Post-Approval Studies (PAS)

The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

The main study limitations derive from the fact that the study population consisted of subjects from the premarket cohort. Premarket studies are typically characterized by providers who are exceptionally skilled, and are therefore likely to provide relatively good results. However, this study is just one component of a two-component PAS requirement. The other component, which is not yet completed, utilizes newly enrolled patients obtained from different sites, which are more likely to be typical of the general population of providers.